Method for manufacturing orally disintegrating tablet, and orally disintegrating tablet

Abstract

A method for manufacturing an orally disintegrating tablet, in which adequate hardness for preventing breakage of the tablet during transport or handling by a medical practitioner or a patient is provided while rapid disintegration is maintained. The method for manufacturing an orally disintegrating tablet according to an embodiment of the present invention comprises spraying or dropping a liquid including hydroxypropyl cellulose having a viscosity in a 2% aqueous solution at 20° C. of 150 mPa·s or more and 400 mPa·s on additives, and performing fluid bed granulation. The liquid including hydroxypropyl cellulose may be sprayed or dropped on the additives so that the content of the hydroxypropyl cellulose with respect to 100 wt % of the orally disintegrating tablet is 0.2 wt % to 5 wt %.

1 . A method for manufacturing an orally disintegrating tablet comprising:
 performing fluid bed granulation while spraying or dropping a liquid including hydroxypropyl cellulose having a viscosity in a 2% aqueous solution at 20° C. of 150 mPa·s or more and 400 mPa·s or less on additives.   
     
     
         2 . The method for manufacturing the orally disintegrating tablet according to  claim 1 , wherein
 the liquid including the hydroxypropyl cellulose is sprayed or dropped on the additives so that a content of the hydroxypropyl cellulose with respect to 100 wt % of the orally disintegrating tablet is 0.2 wt % or more and 5 wt % or less.   
     
     
         3 . The method for manufacturing the orally disintegrating tablet according to  claim 1 , wherein
 the liquid including the hydroxypropyl cellulose is sprayed or dropped on the additives so that the content of the hydroxypropyl cellulose with respect to 100 wt % of the orally disintegrating tablet is 0.2 wt % or more and 2 wt % or less.   
     
     
         4 . The method for manufacturing the orally disintegrating tablet according to  claim 1 , wherein
 the liquid including the hydroxypropyl cellulose is prepared by dissolving hydroxypropyl cellulose and a sweetener; and   the additives are prepared by mixing an excipient and a disintegrant.   
     
     
         5 . The method for manufacturing the orally disintegrating tablet according to one of  claim 1 , wherein
 a pharmaceutically active ingredient is dissolved or dispersed in the liquid including the hydroxypropyl cellulose, or   the pharmaceutically active ingredient is mixed with the additives.   
     
     
         6 . An orally disintegrating tablet, comprising:
 a particle including hydroxypropyl cellulose having a viscosity in a 2% aqueous solution at 20° C. of 150 mPa·s or more and 400 mPa·s or less,   wherein   a bulk density of the particle is 0.40 g/cm 3  or less.   
     
     
         7 . The orally disintegrating tablet according to  claim 6 , wherein
 a content of the hydroxypropyl cellulose with respect to 100 wt % of the orally disintegrating tablet is 0.2 wt % or more and 5 wt % or less.   
     
     
         8 . The orally disintegrating tablet according to  claim 6 , wherein
 a content of the hydroxypropyl cellulose with respect to 100 wt % of the orally disintegrating tablet is 0.2 wt % or more and 2 wt % or less.